A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy

Last updated: June 7, 2023
Sponsor: UCB Pharma
Overall Status: Completed

Phase

3

Condition

Epilepsy

Seizure Disorders

Treatment

Levetiracetam

Clinical Study ID

NCT00150709
N157
  • Ages < 16
  • All Genders

Study Summary

Open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have completed Study N151, or any other applicable pediatric trials of Levetiracetam (Keppra®)
  • Be a patient for whom the treatment of Levetiracetam (Keppra®) would be of potentialbenefit such that the patient/parent(s)/legal guardian and the Investigator agree tocontinue treatment.

Exclusion

Exclusion Criteria:

  • Not be on a ketogenic diet (during the course of this study).
  • Not have seizures too close together to accurately count (i.e., the patient's seizuresmust be countable).

Study Design

Total Participants: 223
Treatment Group(s): 1
Primary Treatment: Levetiracetam
Phase: 3
Study Start date:
January 26, 1998
Estimated Completion Date:
January 25, 2006